FDA clears way for more versatile atherectomy device

Candace Stuart | | Cardiovascular Business | Vascular & Endovascular

The FDA issued clearance for the 4 Fr 1.25 Solid Diamondback 360 Peripheral Orbital Atherectomy System to treat patients with peripheral artery disease (PAD).

Cardiovascular Systems’ new percutaneous devices have two crown designs, a 1.25mm Solid Crown and a 1.25mm Micro Crown, and provide a smaller profile and a more flexible shaft, according to the company. Both designs are 4 Fr sheath compatible and will allow physicians to treat PAD patients below the knee through the groin or to treat the upper leg through the foot.

In March of 2014, the St. Paul, Minn.-based company received FDA clearance for 60cm atherectomy system to treat lesions in the lower leg. The agency gave the Diamondback Orbital Atherectomy System 510(k) clearance in 2007.

Candace Stuart, Contributor

Related Content

‘Fundamental for all patients’: Exploring the benefits of palliative care for stroke survivors
Advancing AI for vascular surgery will require a commitment to data integrity
Industry concerns over paclitaxel-coated devices may have put PAD patients at risk
Genetic predisposition to depression increases CVD risk in women, but not men
Clopidogrel vs. aspirin: Tracking the chronic maintenance period after PCI for different risk groups
IVUS-guided PCI reduces risks in patients with diabetes

Around the web

Radiology Business
Key takeaways from RSNA 2024 for AI, CT, MRI and the radiology staffing shortage

Several key trends were evident at the Radiological Society of North America 2024 meeting, including new CT and MR technology and evolving adoption of artificial intelligence.

Health Imaging
Use of AI opportunistic screening in CT for cardiovascular disease

Ron Blankstein, MD, professor of radiology, Harvard Medical School, explains the use of artificial intelligence to detect heart disease in non-cardiac CT exams.

Health Imaging
New imaging protocols proposed to curb rise of cardiovascular infections

Eleven medical societies have signed on to a consensus statement aimed at standardizing imaging for suspected cardiovascular infections.